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Completed

NCT Number: NCT01817296

Klinefelter Fertility Preservation

Klinefelter syndrome occurs in 1 in 600 males and is a common cause of infertility in men. It appears scar tissue forms in these boys' testicles, leading to progressive destruction over their lifetimes. Advanced reproductive technology can be used to surgically retrieve sperm from these individuals, but these methods have a 50% failure rate in adult Klinefelter patients. Younger men have higher success rates, suggesting that adolescence and young adulthood may be the best time to extract sperm, but these techniques have not been studied in Klinefelter patients younger than 26 years of age. Additionally, there is currently no way to predict which Klinefelter patients will have success with these methods and which of them will not. This trial will explore sperm extraction in Klinefelter syndrome in an age range (12-25 years) that has never been studied, with the ultimate hope of improving the potential for fertility in these patients. The specific goals of this study are to determine the ideal age for sperm retrieval in Klinefelter patients and to establish factors that can be used to predict which of these patients will have a higher likelihood of success with advanced reproductive technology. The hypothesis is that younger Klinefelter patients will have higher sperm retrieval rates.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • diagnosed 47,XXY (Klinefelter syndrome)
  • 12-25 years of age

Exclusion criteria

  • testosterone therapy within past 6 months
  • history of surgery, injury, or infection in the testicle
  • solitary testicle

Treatment and study plan

Testicular biopsy

Procedure

Micro-dissection testicular sperm extraction for sperm retrieval

Primary outcomes

  1. Sperm retrieval rates based on age

    Time frame: Assessed at the end of the 6 month study period

    Results of testicular biopsies will be reviewed for each patient during the 6 month study period

Secondary outcomes

  1. Correlation between sperm retrieval rates and physical and biochemical markers

    Time frame: Assessed at the end of the 6 month study period

    Results of testicular biopsies will be correlated to physical and biochemical markers for each patient after all of the data have been collected, during the 6 month study period.

  2. Correlation between sperm retrieval rates and neurocognitive survey data

    Time frame: Assessed at the end of the 6 month study period

    Results of testicular biopsies will be correlated to neurocognitive survey data for each patient after all of the data have been collected, during the 6 month study period.

Sponsors and collaborators

Lead sponsor

Boston Children's Hospital

Other

Registry information

Official study title

Klinefelter Syndrome: Are we Missing the Optimal Time for Fertility Preservation?

Important dates

Study start
2013
Primary completion
2014
First posted
Mar 25, 2013
Registry last updated
May 15, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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